US FDA Approval

FDA approves device to automatically manage diabetes

Washington, October 02, 2016: Federal regulators have approved a first-of-a-kind implant that can help some diabetes patients manage their disease,…

8 years ago

CPhI Worldwide experts propose new FDA Quality metrics system and recommend Critical Formulation Attributes

SUMMARY of part i: Girish Malhotra President at EPCOT International: The pharmaceutical industry’s biggest shortcoming is a lack of manufacturing…

8 years ago

Glenmark Pharmaceuticals receives ANDA approval for Diclofenac Sodium Gel, 3%

Mumbai, September 20, 2016: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food &…

8 years ago

Aurobindo Pharma receives USFDA Approval for Linezolid Injection

New Delhi, August 29, 2016: Aurobindo Pharma Limited is pleased to announce that the company has received final approval from…

8 years ago

Jubilant Life Sciences receives ANDA approval for Telmisartan Tablets

New Delhi, August 29, 2016: Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has announced that…

8 years ago

Lupin Receives FDA Approval for Potassium Chloride Extended-Release Capsules

Mumbai, August 17, 2016: Pharma Major Lupin Limited announced today that its US subsidiary, Gavis Pharmaceuticals LLC., U.S.A. (collectively Lupin)…

8 years ago

Liquid Biopsy Devices Gain Traction Amid Ongoing Intensive Oncological Research

New Delhi, July 18, 2016: In an official press release on June 1, 2016, the U.S. Food and Drug Authority…

8 years ago

Zydus receives approval from USFDA to initiate Phase 2 clinical trials of Saroglitazar in patients with Non-Alcoholic Steatohepatitis (NASH) of the liver in USA

Ahmedabad, June 07, 2016: Zydus Cadila, a research-driven, global healthcare provider, today announced that USFDA has approved the company’s plan to…

8 years ago

USFDA extends time for Dr Reddy’s to respond on warning letters

Hyderabad, November 27, 2015: The US Food and Drug Administration (USFDA) has extended deadline for Dr Reddy’s laboratories Ltd to…

9 years ago

Glenmark gets USFDA nod for generic diabetes treatment drug

New Delhi, June 01, 2015 Glenmark Pharmaceuticals today said it has received the final approval from US health regulator for…

9 years ago